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Internet-based Program for Prevention and Early Intervention of Adolescent Depression

U

University of Chile

Status

Completed

Conditions

Depressive Symptoms

Treatments

Other: Control
Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish)

Study type

Interventional

Funder types

Other

Identifiers

NCT03521388
FONDECYT 1161696

Details and patient eligibility

About

Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.

Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.

Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.

Enrollment

947 patients

Sex

All

Ages

13 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Attending from ninth grade to eleventh grade in the eight participating schools.
  • Informed consent and informed assent.
  • Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.

Exclusion criteria

  • High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
  • Current treatment with antidepressant drugs.
  • Current treatment with psychotherapy.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

947 participants in 2 patient groups

Intervention group
Experimental group
Description:
The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months. The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components. The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd \& 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program.
Treatment:
Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish)
Control group
Other group
Description:
The comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated.
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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